Nutritional AssessmentsNCT06536270
Development of a Web-Based Food Frequency Questionnaire and Diet Quality Score for Turkish Adults
An observational study of Nutritional Assessments and Nutritional Quality, run by Medipol University at 1 site in Turkey (Türkiye).
Trial summary
This research aims to adapt and validate the web-based eNutri Food Frequency Questionnaire (FFQ) and Diet Quality Score (DQS) for the Turkish population, addressing the current gap in dietary assessment tools for Turkey. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Nutritional Assessments, Nutritional Quality
- What is being tested?
- A validation and reproducibility study with a cross-sectional component
- How many people
- 151 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 19 May 2024to 30 Dec 2024
- How long will I take part?
- 2 Weeks
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study population will consist of Turkish adults aged 18-65 years who reside in Turkey.
Who may be able to join
- Adults aged 18-65 years.
- No diagnosed medical conditions (e.g., diabetes, heart disease, cancer, gastrointestinal conditions).
- Not pregnant or lactating.
- No food allergies or intolerances.
- Not following a specialized diet (e.g., vegan, weight-loss, sports nutrition regimen; vegetarians are eligible).
- Not receiving face-to-face nutritional services or dietary advice from a medical professional.
- Not participating in another nutrition study.
- Residing in Turkey.
Who cannot join
- Individuals with any diagnosed medical conditions.
- Pregnant or lactating women.
- Individuals with food allergies or intolerances.
- Those following a specialized diet (except vegetarians).
- Participants currently receiving face-to-face nutritional services or dietary advice.
- Individuals involved in another nutrition study.
- Individuals residing outside of Turkey.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul Medipol University
Istanbul, Beykoz, 34810
About this study
Official title: Development of a Web-Based Food Frequency Questionnaire and Diet Quality Score for Turkish Adults: Validity and Reliability
This research aims to adapt and validate the web-based eNutri Food Frequency Questionnaire (FFQ) and Diet Quality Score (DQS) for the Turkish population, addressing the current gap in dietary assessment tools for Turkey. The study involves adapting the UK-based eNutri FFQ to reflect Turkish dietary habits, including revising the food list, capturing portion size photos, and incorporating local food composition data. The revised FFQ will be validated against three 24-hour dietary recalls and tested for reproducibility.
Read the detailed description
Background: Non-communicable diseases (NCDs), such as cardiovascular diseases, are important global health concerns. Accurate dietary assessment is pivotal in understanding the relationship between food intake and health outcomes. Presently, there is a notable absence of a comprehensive dietary assessment tool tailored for the Turkish population.
Objective: The primary objective of this research is to adapt and validate the web-based eNutri Food Frequency Questionnaire (FFQ) and Diet Quality Score (DQS) for the Turkish population, addressing the current gap in dietary assessment methods.
Design and Proposed Analysis: The first part of the study will involve adapting the UK-based e-Nutri FFQ to reflect dietary habits of Turkish adults (eNutri-Turkey), such as revising the food list, taking portion size photos, and incorporating Turkish food composition data. The revised FFQ delivered online will be validated against three 24-hour recalls by phone (reference method) and the FFQ will be administered twice to assess reproducibility. The study will employ Cronbach's Alpha for internal consistency and the Bland-Altman method for validity. Additionally, inter-rater reliability and reproducibility will be assessed through Cohen's Kappa and ICC analysis, respectively. The eNutri DQS will be adapted in accordance with Turkish dietary guidelines. Following the adaptation, its validity will be assessed using existing Turkish population nutrient data. This analysis will involve retrospectively calculating the DQS and examining its associations with key risk markers of chronic diseases (BMI, blood pressure, blood glucose and cholesterol levels). Additionally, two qualitative studies will be conducted before starting the validation study. Dietitians and nutrition academics from Turkey (n=10) will provide insights on the suitability and effectiveness of eNutri-Turkey through one-to-one interviews. Feedback received will be used to improve the FFQ and DQS.
- Conditions
- Nutritional Assessments, Nutritional Quality
- Being tested
- A validation and reproducibility study with a cross-sectional component
- Keywords
- Food Frequency Questionnaire, Dietary Assessment, Diet Quality
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A validation and reproducibility study with a cross-sectional componentOther
The primary intervention in this study involves adapting and validating the eNutri web-based Food Frequency Questionnaire and Diet Quality Score for the Turkish population.
What is being measured
The primary outcome is the main question the study is designed to answer.
Validity of the web-based FFQ
Assesses the validity of the adapted eNutri FFQ by comparing its results with those from three 24-hour dietary recalls. Validity is evaluated based on nutrient intake measurements.
Measured: 14-day period
Reproducibility of the web-based FFQ
Measures reproducibility by administering the FFQ twice to participants and analyzing the consistency of the results. Consistency of results; statistical measures will be used for analysis.
Measured: 14-day period
Secondary outcomes (2)
Usability of the web-based FFQ
Evaluates usability through participant feedback on a scale (e.g., Likert scale) on the clarity and ease of use of the FFQ and portion size images.
Measured: Immediately after the first FFQ administration
Usability Comparison of 24-Hour Recall and web-based FFQ
Compares dietary intake data obtained from the 24-hour recall method (reference method) with that obtained from the FFQ administered after the second FFQ to assess usability.
Measured: Immediately after the second FFQ administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2024
- Study start19 May 2024
- Primary completion30 Dec 2024
- Study completion30 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nutritional AssessmentsStudies of the same condition, open and under way.
- More trials run by Medipol UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 151 participants (actual)
- Target duration
- 2 Weeks
Sponsor and investigators
- Lead sponsor
- Medipol University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Reading
- Responsible party
- Principal investigator, Merve GÜNEY COŞKUN, Medipol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06536270
- Sponsor's protocol ID
- E-10840098-772.02-6576
- Status last verified
- Jan 2025
- First submitted
- 29 Jul 2024
- Last updated
- 22 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The Individual Participant Data (IPD) sharing plan does not include making anonymized data available to other researchers. Instead, data access will be provided only through secure platforms to researchers with approved proposals, ensuring adherence to confidentiality and ethical standards. The data will be shared through publication, with clear terms outlined to safeguard participant privacy.
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Web-Based Food Frequency Questionnaire and Diet Quality Score for Turkish Adults: Validity and Reliability
- ClinicalTrials.gov ID
- NCT06536270
- Acronym / sponsor ID
- E-10840098-772.02-6576
- Conditions
- Nutritional Assessments, Nutritional Quality
- Keywords
- Food Frequency Questionnaire, Dietary Assessment, Diet Quality
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 151 participants (actual)
- Lead sponsor
- Medipol UniversityUniversity, hospital or other
- Collaborators
- University of Reading
- Study start
- 19 May 2024 (actual)
- Primary completion
- 30 Dec 2024 (actual)
- Study completion
- 30 Dec 2024 (actual)
- First posted
- 2 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This research aims to adapt and validate the web-based eNutri Food Frequency Questionnaire (FFQ) and Diet Quality Score (DQS) for the Turkish population, addressing the current gap in dietary assessment tools for Turkey. The study involves adapting the UK-based eNutri FFQ to reflect Turkish dietary habits, including revising the food list, capturing portion size photos, and incorporating local food composition data. The revised FFQ will be validated against three 24-hour dietary recalls and tested for reproducibility.
Detailed description
Background: Non-communicable diseases (NCDs), such as cardiovascular diseases, are important global health concerns. Accurate dietary assessment is pivotal in understanding the relationship between food intake and health outcomes. Presently, there is a notable absence of a comprehensive dietary assessment tool tailored for the Turkish population.
Objective: The primary objective of this research is to adapt and validate the web-based eNutri Food Frequency Questionnaire (FFQ) and Diet Quality Score (DQS) for the Turkish population, addressing the current gap in dietary assessment methods.
Design and Proposed Analysis: The first part of the study will involve adapting the UK-based e-Nutri FFQ to reflect dietary habits of Turkish adults (eNutri-Turkey), such as revising the food list, taking portion size photos, and incorporating Turkish food composition data. The revised FFQ delivered online will be validated against three 24-hour recalls by phone (reference method) and the FFQ will be administered twice to assess reproducibility. The study will employ Cronbach's Alpha for internal consistency and the Bland-Altman method for validity. Additionally, inter-rater reliability and reproducibility will be assessed through Cohen's Kappa and ICC analysis, respectively. The eNutri DQS will be adapted in accordance with Turkish dietary guidelines. Following the adaptation, its validity will be assessed using existing Turkish population nutrient data. This analysis will involve retrospectively calculating the DQS and examining its associations with key risk markers of chronic diseases (BMI, blood pressure, blood glucose and cholesterol levels). Additionally, two qualitative studies will be conducted before starting the validation study. Dietitians and nutrition academics from Turkey (n=10) will provide insights on the suitability and effectiveness of eNutri-Turkey through one-to-one interviews. Feedback received will be used to improve the FFQ and DQS.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Target follow-up
- 2 Weeks
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will consist of Turkish adults aged 18-65 years who reside in Turkey.
Key inclusion criteria (8 listed)
- Adults aged 18-65 years.
- No diagnosed medical conditions (e.g., diabetes, heart disease, cancer, gastrointestinal conditions).
- Not pregnant or lactating.
- No food allergies or intolerances.
- Not following a specialized diet (e.g., vegan, weight-loss, sports nutrition regimen; vegetarians are eligible).
Key exclusion criteria (7 listed)
- Individuals with any diagnosed medical conditions.
- Pregnant or lactating women.
- Individuals with food allergies or intolerances.
- Those following a specialized diet (except vegetarians).
- Participants currently receiving face-to-face nutritional services or dietary advice.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| A validation and reproducibility study with a cross-sectional componentThe primary intervention in this study involves adapting and validating the eNutri web-based Food Frequency Questionnaire and Diet Quality Score for the Turkish population. | Other | – |
Primary outcome
Validity of the web-based FFQ
Time frame: 14-day period
Assesses the validity of the adapted eNutri FFQ by comparing its results with those from three 24-hour dietary recalls. Validity is evaluated based on nutrient intake measurements.
Reproducibility of the web-based FFQ
Time frame: 14-day period
Measures reproducibility by administering the FFQ twice to participants and analyzing the consistency of the results. Consistency of results; statistical measures will be used for analysis.
2 secondary outcomes
Usability of the web-based FFQ
Time frame: Immediately after the first FFQ administration
Usability Comparison of 24-Hour Recall and web-based FFQ
Time frame: Immediately after the second FFQ administration
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2025.
- Individual participant dataSharing planned: No. The Individual Participant Data (IPD) sharing plan does not include making anonymized data available to other researchers. Instead, data access will be provided only through secure platforms to researchers with approved proposals, ensuring adherence to confidentiality and ethical standards. The data will be shared through publication, with clear terms outlined to safeguard participant privacy.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Nutritional Assessments and Nutritional Quality, run by Medipol University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Validity of the web-based FFQ (time frame: 14-day period). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2025.